Company · US
Skeletal Dynamics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (3 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 19 |
| HWC | Screw, Fixation, Bone | 5 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 4 |
| OZI | Internal Hinged Elbow Fixator | 3 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 2 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| HRX | Arthroscope | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2026 | K261770 | Suture Button Repair System Skeletal Dynamics, Inc. | MBI |
| Mar 23, 2026 | K254288 | Clavicle Fixation System Skeletal Dynamics, Inc. | HRS |
| Nov 13, 2025 | K252949 | Geminus Volar Distal Radius Plating System Skeletal Dynamics, Inc. | HRS |
| Nov 14, 2024 | K242436 | Proximal Humerus Fixation System Skeletal Dynamics, Inc. | HRS |
| Nov 1, 2024 | K243381 | Total Wrist Arthroplasty System (TWA) Skeletal Dynamics, Inc. | JWJ |
| Sep 26, 2024 | K241815 | Protean Fragment Plating System Skeletal Dynamics, Inc. | HRS |
| Aug 1, 2024 | K242055 | Freefix Forearm Plating System Skeletal Dynamics, Inc. | HRS |
| Jul 19, 2024 | K240835 | Suture Button Repair System Skeletal Dynamics, Inc. | MBI |
| Jul 3, 2024 | K233574 | Total Wrist Arthroplasty System (TWA) Skeletal Dynamics | JWJ |
| Dec 15, 2023 | K231447 | Double Internal Joint Stabilizer- Elbow Skeletal Dynamics, Inc. | OZI |
| Sep 28, 2023 | K231188 | ALIGN Radial Head System Skeletal Dynamics, Inc. | KWI |
| Aug 28, 2023 | K231623 | Distal Elbow Plating System Skeletal Dynamics, Inc. | HRS |
| May 10, 2023 | K223318 | Internal Joint Stabilizer - Elbow Skeletal Dynamics, Inc. | OZI |
| Apr 28, 2023 | K230908 | Hand Trauma Threaded Nail System Skeletal Dynamics, Inc. | HWC |
| May 12, 2022 | K220723 | Hand Trauma Screw System Skeletal Dynamics, Inc. | HWC |
| Jan 13, 2022 | K213895 | Distal Humerus Plating System Skeletal Dynamics, Inc. | HRS |
| Sep 30, 2021 | K211439 | Small Bone Nailing System Skeletal Dynamics, Inc. | HTY |
| Oct 13, 2020 | K201962 | Skeletal Dynamics Ulnar Shortening Plating System Skeletal Dynamics, Inc. | HRS |
| Jul 16, 2020 | K201662 | REDUCT® Headless Compression Screw System Skeletal Dynamics, Inc. | HWC |
| Jun 1, 2020 | K200538 | Skeletal Dynamics Forearm Plating System Skeletal Dynamics, Inc. | HRS |
| May 14, 2020 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System Skeletal Dynamics, Inc. | HRS |
| May 14, 2020 | K200367 | Distal Humerus Plating System Skeletal Dynamics, Inc. | HRS |
| Oct 10, 2018 | K182492 | Geminus Volar Distal Radius Plate System Skeletal Dynamics, LLC | HRS |
| Apr 11, 2018 | K180744 | Stablyx CMC Arthroplasty Implant System Skeletal Dynamics, LLC | KYI |
| Dec 22, 2017 | K172688 | Align Radial Head System Skeletal Dynamics, LLC | KWI |
| Jun 27, 2017 | K171590 | Distal Elbow Plating System Skeletal Dynamics, LLC | HRS |
| Dec 31, 2015 | K153208 | Internal Joint Stabilizer - Elbow Skeletal Dynamics, LLC | OZI |
| May 12, 2015 | K150675 | Dorsal Spanning Plate Skeletal Dynamics, LLC | HRS |
| Jan 13, 2015 | K143624 | Headless Compression Screw System Skeletal Dynamics, LLC | HWC |
| Aug 28, 2014 | K140892 | DISTAL ELBOW PLATING SYSTEM Skeletal Dynamics, LLC | HRS |
| Apr 7, 2014 | K140372 | FRAGMENT PLATE SYSTEM Skeletal Dynamics, LLC | HRS |
| Jan 18, 2013 | K122310 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM Skeletal Dynamics, LLC | HRS |
| Oct 3, 2012 | K122737 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM Skeletal Dynamics, LLC | HRS |
| Dec 30, 2011 | K111068 | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 Skeletal Dynamics, LLC | KYI |
| Dec 13, 2011 | K112672 | HEADLESS COMPRESSION SCREW Skeletal Dynamics, LLC | HWC |
| Aug 23, 2011 | K111620 | SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS Skeletal Dynamics, LLC | HRS |
| Dec 7, 2010 | K102103 | SKELETAL DYNAMICS STERILIZATION TRAYS Skeletal Dynamics, LLC | KCT |
| Oct 4, 2010 | K092723 | AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM Skeletal Dynamics, LLC | HRX |
| Aug 3, 2010 | K092721 | ALIGN RADIAL HEAD SYSTEM Skeletal Dynamics, LLC | KWI |
| Jun 29, 2010 | K092720 | WRIST ARTHRODESIS NAIL SYSTEM Skeletal Dynamics, LLC | HSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Skeletal Dynamics Align Radial Stems, Prosthesis, Elbow, Hemi
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/o Terminated |
KWI | K092721 |